History of ICH-GCPBackground• Need for safe and efficient products for varioushealth problems• Drug development is expensive and time consuming• Need for efficient quality systems• Global drug market• Existence of national laws and regulations for drugdevelopment
History of ICH-GCPPurpose• To harmonize the regulations and guidelines fordrug developmentParticipants• Regulatory agency/industry representatives fromEurope, Japan and US+ WHO, Canada, Nordic group, Australia
History of ICH-GCPGoal• To provide a unified standard to facilitate themutual acceptance of clinical data by theregulatory authorities• Remove redundancy /duplication indevelopment and review process
History of ICH-GCPProcess• Developed guidelines applicable for• Drugs• Biologics• Medical devices• Approved by ICH members• Adopted by National Regulatory Authorities
Good Clinical Practice (GCP)An international ethical and scientific qualitystandard for designing, conducting, recording, andreporting trials that involve the participation ofhuman subjectsPublic assurance that the rights, safety, and well-being of trial subjects are protected• Consistent with the Declaration of Helsinki• Results in credible data
The end product of clinicalresearchProtocolData Datacollection ManagementData StudyAnalysis ReportPositive (or negative) data can lead to arecommendation to use (or not to use) atreatment.
Who are responsible for GCPThe responsibility for GCP is shared by allof the parties involved, including :sponsorsinvestigators and site staffcontract research organizations (CROs)ethics committeesregulatory authoritiesresearch subjects.
WHO Principles of GCPPrinciple 1 : Ethical ConductResearch involving humans should bescientifically sound and conducted inaccordance with basic ethical principles,which have their origin in the Declaration ofHelsinki. Three basic ethical principles ofequal importance, namely respect forpersons, beneficence, and justice,permeate all other GCP principles.
WHO Principles of GCPPrinciple 2 Research Described in a ProtocolResearch involving humans should bescientifically justified and described in a clear,detailed protocol.
WHO Principles of GCPPrinciple 3: Risk Identification :Before research involving humans is initiated,foreseeable risks and discomforts and anyanticipated benefit (s) for the individualresearch subject and society should beidentified. Research of investigational productsor procedures should be supported byadequate non-clinical and, when applicable,clinical information.
WHO Principles of GCPPrinciple 4: Benefit-Risk AssessmentResearch involving humans should be initiatedonly if the anticipated benefit(s) for theindividual research subject and society clearlyoutweigh the risks. Although the benefit of theresults of the trial to science and society shouldbe taken into account, the most importantconsiderations are those related to the rights,safety, and well-being of the research subjects.
WHO Principles of GCPPrinciple 5 : Review by IEC/IRBResearch involving humans should receiveindependent ethics committee/institutionalreview board (IEC/IRB) approval/favourableopinion prior to initiation
WHO Principles of GCPPrinciple 6 : Protocol ComplianceResearch involving humans should beconducted in compliance with the approvedprotocol.
WHO Principles of GCPPrinciple 7 : Informed ConsentFreely given informed consent should beobtained from every subject prior to researchparticipation in accordance with nationalculture (s) and requirements. When a subjectis not capable of giving informed consent,the permission of a legally authorizedrepresentative should be obtained inaccordance with applicable law.
WHO Principles of GCPPrinciple 8 : Continuing Review/OngoingBenefit-Risk AssessmentResearch involving humans should becontinued only if the benefit-risk profileremains favorable.
WHO Principles of GCPPrinciple 9 : Investigator QualificationsQualified and duly licensed medical personnel(i.e. physician or, when appropriate, dentist)should be responsible for the medical care ofresearch subjects, and for any medicaldecision (s) made on their behalf.
WHO Principles of GCPPrinciple 10: Staff QualificationsEach individual involved in conducting a trialshould be qualified by education, training,and experience to perform his or herrespective task (s) and currently licensed todo so, where required.
WHO Principles of GCPPrinciple 11 : RecordsAll clinical trial information should berecorded, handled, and stored in a way thatallows its accurate reporting, interpretation,and verification.
WHO Principles of GCPPrinciple 12 : Confidentiality/PrivacyThe confidentiality of records that couldidentify subjects should be protected,respecting the privacy and confidentialityrules in accordance with the applicableregulatory requirement (s)
WHO Principles of GCPPrinciple 13 : Good Manufacturing PracticeInvestigational products should bemanufactured, handled, and stored inaccordance with applicable GoodManufacturing Practice (GMP) and should beused in accordance with the approvedprotocol.
WHO Principles of GCPPrinciple 14: Quality SystemsSystems with procedures that assure thequality of every aspect of the trial should beimplemented.